Leukaemia (Acute Lymphoblastic)Phase 1ThINKK-01NCT07518654
Phase I Clinical Trial of ThINKK Adoptive Immunotherapy After Allogeneic Hematopoietic Transplantation in Children With Leukemia or Neuroblastoma
A Phase 1 study testing Therapeutic Inducers of Natural Killer Killing (ThINKK) in people with Leukaemia (Acute Lymphoblastic) and Leukaemia (Acute Myeloid), run by Michel Duval at 2 sites in Canada.
Trial summary
A first-in-class adoptive immunotherapy we called ThINKK, for Therapeutic Inducers of Natural Killer (NK) cell Killing, have been designed for use after hematopoietic stem cell transplantation (HSCT), where the proper stimulation of graft-derived NK cells has been shown to prevent relapse. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Leukaemia (Acute Lymphoblastic), Leukaemia (Acute Myeloid), Neuroblastoma
- What is being tested?
- Therapeutic Inducers of Natural Killer Killing (ThINKK)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesCanada
- Study dates
- 1 May 2026to 1 May 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between 2 and less than 13 years old at time of informed consent form signature.
- Diagnosis of acute leukemia or neuroblastoma.
- Allogenic hematopoietic stem cell transplantation 30 to 90 days prior to eligibility confirmation.
- Blood NK cell counts ≥ 100 x 10E+6 cells/L at least once before eligibility confirmation.
- Life expectancy of ≥ 3 months per investigator's judgment at time of eligibility confirmation.
- Patient or legally acceptable representative has provided informed consent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
Who cannot join
- Current grade 3 or 4 acute GvHD (per MAGIC criteria).
- Relapse of primary malignancy, or any other active malignancy.
- For leukemia, defined as either morphological relapse or Minimal Residual Disease (MRD) ≥0.01% as measured by flow cytometry. MRD detected by polymerase chain reaction (PCR) does not constitute an exclusion criterion.
- For neuroblastoma, defined as a progressive disease.
- Ongoing therapy with systemic corticosteroids (equivalent to a prednisone dose >0.5 mg/kg/day). Patients actively undergoing corticosteroid tapering during Screening may be enrolled once they have reached a prednisone-equivalent dose ≤ 0.5 mg/kg/day with Sponsor-Investigator approval, with the expectation that the taper will continue.
- Ongoing systemic therapy with cyclosporine.
Show all 17Show fewer
- Administration or planned administration of any prohibited treatment listed in ad hoc section.
- Aspartate aminotransferase and alanine aminotransferase serum levels ≥5 times the upper limit of normal.
- Direct bilirubin serum levels ≥3 times the ULN (unless due to Gilbert syndrome).
- Baseline estimated glomerular filtration rate < 50 mL/min/1.73 m2, as determined using the Bedside Schwartz equation for < 18 years of age.
- Grade 4 diarrhea (ie, life-threatening consequences with urgent intervention indicated).
- O2 Sat saturation <90% on room air by pulse oximetry.
- Uncontrolled life-threatening symptomatic infection(s).
- Blood pressure below the 5th percentile for age, sex, and height last 24 hours.
- Ongoing therapy with intravenous vasopressor agent.
- Any condition that, in the opinion of the Investigator, would compromise the safety of the patient, would prevent full participation in this study, or would interfere with the evaluation of any study endpoints.
- Pregnancy or breastfeeding or absence of highly effective methods of contraception for males and females of childbearing potential who engage in heterosexual intercourse
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
CHU Sainte-Justine
Montreal, Quebec, H3T1C5
Henrique Bittencourt, MD, 5143454931 ext. 2724, henrique.bittencourt.med@ssss.gouv.qc.ca
Henrique Bittencourt, MD
The Hospital for Sick Children
Toronto, Ontario, M5G1E8
Joerg Krueger, MD, 4168131500, joerg.krueger@sickkids.ca
Joerg Krueger, MD
About this study
Official title: Phase I Clinical Trial of Therapeutic Inducers of Natural Killer Killing (ThINKK) Adoptive Immunotherapy: Feasibility, Safety and Pharmacodynamics in Children Undergoing Allogenic Hematopoietic Transplantation for Leukemia or Neuroblastoma
A first-in-class adoptive immunotherapy we called ThINKK, for Therapeutic Inducers of Natural Killer (NK) cell Killing, have been designed for use after hematopoietic stem cell transplantation (HSCT), where the proper stimulation of graft-derived NK cells has been shown to prevent relapse.
ThINKK immunotherapy builds on our earlier research on NK cells and plasmacytoid dendritic cells (PDC) in cord blood and after HSCT. PDC are the sentinels of the immune system. Upon viral nucleic acids detection, PDC secrete a vast array of chemokines and cytokines that stimulate NK cells. PDC stimulation enhances NK cells killing of infected cells that express stress-induced molecules. Cancer cells also express stress-related molecules at their surface. However, NK cells do not receive PDC stimulation when fighting cancer. ThINKK therapy is designed to provide this necessary stimulation.
Read the detailed description
Primary Objective:
To assess the safety and tolerability of ThINKK adoptive immunotherapy by determination of the Maximum Tolerated Dose (MTD) in patients who has undergone allogenic HSCT for acute leukemia (ALL or AML) or neuroblastoma.
- Secondary Objectives:
- To demonstrate the feasibility of delivering (manufacturing and administrating) ThINKK adoptive immunotherapy after HSCT.
- To assess biological effect at MTD (pharmacodynamic studies).
- Conditions
- Leukaemia (Acute Lymphoblastic), Leukaemia (Acute Myeloid), Neuroblastoma, Neuroblastoma, Metastatic, Leukaemia, Lymphoblastic, Acute, Leukemia Acute Myeloid
- Being tested
- Therapeutic Inducers of Natural Killer Killing (ThINKK)
- Keywords
- Thinkk, NK cells, pdc, immunotherapy
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute, Neuroblastoma, Neoplasm Metastasis, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Paroxysmal nonkinesigenic dyskinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Inducers of Natural Killer Killing (ThINKK)Drug
Also called ThINKK
This study uses an adaptation of the classical 3+3 dose-escalation model. The Maximum Tolerated Dose (MTD) is determined as the highest dose level at which six patients are treated with no unacceptable increase in acute GvHD risk and with no more than one patient experiencing a DLT. The first cohort (3 patients) will receive 7.5 M ThINKK/m2 weekly for 4 weeks. Dose distribution for the escalation levels will be guided by the pharmacodynamic data from the initial cohort.. If the preliminary data show that TRAIL expression remains stable at Day +8, dose level 2 will be set at 15 × 10^6 / m2 BSA weekly, and dose level 3 at 30 × 10^6 / m2 BSA weekly. If the data instead indicate the need to shorten the dosing interval to maintain TRAIL expression, dose level 2 will be set at 7.5 × 10^6 / m2 BSA bi-weekly and dose level 3 at 15 × 10^6 / m2 BSA bi-weekly.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: Therapeutic Inducers of Natural Killer Killing (ThINKK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events and serious adverse events
Measured: From first study drug administration to 4 weeks after last administration
Incidence of dose-limiting toxicities
Defined as: (1) Adverse event (excluding cytopenias) grade ≥ 3 considered to be possibly, probably or definitively related to the investigational product, (2) Cytopenia (anemia, neutropenia or thrombocytopenia) grade ≥ 4 considered to be possibly, probably or definitively related to the investigational product, (3) Grade ≥ 3 ICANS, (4) Grade ≥ 3 CRS and (5) Overall clinical grade ≥ 3 acute GvHD (MAGIC criteria)
Measured: From first study drug administration to 4 weeks after last administration
Incidence and severity of treatment-related adverse events
Measured: From first study drug administration to 4 weeks after last administration
Secondary outcomes (7)
Number of patients who received all infusions
Measured: At the end of week 4
Number of infusions received per patient
Measured: At the end of week 4
Time elapsed between confirmation of eligibility and first infusion
Measured: At day 1
Percentage (%) of viable ThINKK cells at the time of infusion
Measured: Day of infusion
Assessment of NK surface biomarkers
Measured: From first study drug administration to 1 week after last administration
Assessment of plasmatic biomarkers by Olink®
Measured: From first study drug administration to 1 week after last administration
Assessment of the global immune responses by single cell RNA sequencing
Measured: Prior to first infusion and up to 1 week post last infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Leukaemia (Acute Lymphoblastic)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Adapted 3+3 design
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michel Duval
- Sponsor type
- University, hospital or other
- Collaborators
- Héma-Québec, ExCellThera inc., Centre C3i
- Responsible party
- Sponsor-investigator, Michel Duval, St. Justine's Hospital
- Investigators
- Michel Duval, MD, Principal investigator, St. Justine's HospitalSabine Herblot, PhD, Study director, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518654
- Sponsor's protocol ID
- ThINKK-01
- Acronym
- ThINKK-01
- Status last verified
- Apr 2026
- First submitted
- 20 Feb 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Currently reviewing our local regulations about individual patient data sharing (Canada)
Publications
Cordeau M, Belounis A, Lelaidier M, Cordeiro P, Sartelet H, Herblot S, Duval M. Efficient Killing of High Risk Neuroblastoma Using Natural Killer Cells Activated by Plasmacytoid Dendritic Cells. PLoS One. 2016 Oct 7;11(10):e0164401. doi: 10.1371/journal.pone.0164401. eCollection 2016.
PubMed 27716850Belounis A, Ayoub M, Cordeiro P, Lemieux W, Teira P, Haddad E, Herblot S, Duval M. Patients' NK cell stimulation with activated plasmacytoid dendritic cells increases dinutuximab-induced neuroblastoma killing. Cancer Immunol Immunother. 2020 Sep;69(9):1767-1779. doi: 10.1007/s00262-020-02581-0. Epub 2020 Apr 27.
PubMed 32342128Poirier N, Paquin V, Leclerc S, Lisi V, Marmolejo C, Affia H, Cordeiro P, Theoret Y, Haddad E, Andelfinger G, Lavallee VP, Duval M, Herblot S. Therapeutic Inducers of Natural Killer cell Killing (ThINKK): preclinical assessment of safety and efficacy in allogeneic hematopoietic stem cell transplant settings. J Immunother Cancer. 2024 May 15;12(5):e008435. doi: 10.1136/jitc-2023-008435.
PubMed 38754915Diaz-Rodriguez Y, Cordeiro P, Belounis A, Herblot S, Duval M. In vitro differentiated plasmacytoid dendritic cells as a tool to induce anti-leukemia activity of natural killer cells. Cancer Immunol Immunother. 2017 Oct;66(10):1307-1320. doi: 10.1007/s00262-017-2022-y. Epub 2017 May 29.
PubMed 28555259Lelaidier M, Diaz-Rodriguez Y, Cordeau M, Cordeiro P, Haddad E, Herblot S, Duval M. TRAIL-mediated killing of acute lymphoblastic leukemia by plasmacytoid dendritic cell-activated natural killer cells. Oncotarget. 2015 Oct 6;6(30):29440-55. doi: 10.18632/oncotarget.4984.
PubMed 26320191Charrier E, Cordeiro P, Brito RM, Mezziani S, Herblot S, Le Deist F, Duval M. Reconstitution of maturating and regulatory lymphocyte subsets after cord blood and BMT in children. Bone Marrow Transplant. 2013 Mar;48(3):376-82. doi: 10.1038/bmt.2012.176. Epub 2012 Oct 15.
PubMed 23064038Charrier E, Cordeiro P, Brito RM, Harnois M, Mezziani S, Herblot S, Le Deist F, Duval M. Impaired interferon-alpha production by plasmacytoid dendritic cells after cord blood transplantation in children: implication for post-transplantation toll-like receptor ligand-based immunotherapy. Biol Blood Marrow Transplant. 2014 Oct;20(10):1501-7. doi: 10.1016/j.bbmt.2014.06.007. Epub 2014 Aug 14.
PubMed 25128615
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of Therapeutic Inducers of Natural Killer Killing (ThINKK) Adoptive Immunotherapy: Feasibility, Safety and Pharmacodynamics in Children Undergoing Allogenic Hematopoietic Transplantation for Leukemia or Neuroblastoma
- ClinicalTrials.gov ID
- NCT07518654
- Acronym / sponsor ID
- ThINKK-01 / ThINKK-01
- Conditions
- Leukaemia (Acute Lymphoblastic), Leukaemia (Acute Myeloid), Neuroblastoma, Neuroblastoma, Metastatic, Leukaemia, Lymphoblastic, Acute, Leukemia Acute Myeloid
- Keywords
- Thinkk, NK cells, pdc, immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Michel DuvalUniversity, hospital or other
- Collaborators
- Héma-Québec, ExCellThera inc., Centre C3i
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A first-in-class adoptive immunotherapy we called ThINKK, for Therapeutic Inducers of Natural Killer (NK) cell Killing, have been designed for use after hematopoietic stem cell transplantation (HSCT), where the proper stimulation of graft-derived NK cells has been shown to prevent relapse.
ThINKK immunotherapy builds on our earlier research on NK cells and plasmacytoid dendritic cells (PDC) in cord blood and after HSCT. PDC are the sentinels of the immune system. Upon viral nucleic acids detection, PDC secrete a vast array of chemokines and cytokines that stimulate NK cells. PDC stimulation enhances NK cells killing of infected cells that express stress-induced molecules. Cancer cells also express stress-related molecules at their surface. However, NK cells do not receive PDC stimulation when fighting cancer. ThINKK therapy is designed to provide this necessary stimulation.
Detailed description
Primary Objective:
To assess the safety and tolerability of ThINKK adoptive immunotherapy by determination of the Maximum Tolerated Dose (MTD) in patients who has undergone allogenic HSCT for acute leukemia (ALL or AML) or neuroblastoma.
- Secondary Objectives:
- To demonstrate the feasibility of delivering (manufacturing and administrating) ThINKK adoptive immunotherapy after HSCT.
- To assess biological effect at MTD (pharmacodynamic studies).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Adapted 3+3 design
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Therapeutic Inducers of Natural Killer Killing (ThINKK) |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Between 2 and less than 13 years old at time of informed consent form signature.
- Diagnosis of acute leukemia or neuroblastoma.
- Allogenic hematopoietic stem cell transplantation 30 to 90 days prior to eligibility confirmation.
- Blood NK cell counts ≥ 100 x 10E+6 cells/L at least once before eligibility confirmation.
- Life expectancy of ≥ 3 months per investigator's judgment at time of eligibility confirmation.
Key exclusion criteria (17 listed)
- Current grade 3 or 4 acute GvHD (per MAGIC criteria).
- Relapse of primary malignancy, or any other active malignancy.
- Ongoing therapy with systemic corticosteroids (equivalent to a prednisone dose >0.5 mg/kg/day). Patients actively undergoing corticosteroid tapering during Screening may be enrolled once they have reached a prednisone-equivalent dose ≤ 0.5 mg/kg/day with Sponsor-Investigator approval, with the expectation that the taper will continue.
- Ongoing systemic therapy with cyclosporine.
- Administration or planned administration of any prohibited treatment listed in ad hoc section.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Inducers of Natural Killer Killing (ThINKK)Also: ThINKKThis study uses an adaptation of the classical 3+3 dose-escalation model. The Maximum Tolerated Dose (MTD) is determined as the highest dose level at which six patients are treated with no unacceptable increase in acute GvHD risk and with no more than one patient experiencing a DLT. The first cohort (3 patients) will receive 7.5 M ThINKK/m2 weekly for 4 weeks. Dose distribution for the escalation levels will be guided by the pharmacodynamic data from the initial cohort.. If the preliminary data show that TRAIL expression remains stable at Day +8, dose level 2 will be set at 15 × 10^6 / m2 BSA weekly, and dose level 3 at 30 × 10^6 / m2 BSA weekly. If the data instead indicate the need to shorten the dosing interval to maintain TRAIL expression, dose level 2 will be set at 7.5 × 10^6 / m2 BSA bi-weekly and dose level 3 at 15 × 10^6 / m2 BSA bi-weekly. | Drug | Treatment |
Primary outcome
Incidence and severity of treatment-emergent adverse events and serious adverse events
Time frame: From first study drug administration to 4 weeks after last administration
Incidence of dose-limiting toxicities
Time frame: From first study drug administration to 4 weeks after last administration
Defined as: (1) Adverse event (excluding cytopenias) grade ≥ 3 considered to be possibly, probably or definitively related to the investigational product, (2) Cytopenia (anemia, neutropenia or thrombocytopenia) grade ≥ 4 considered to be possibly, probably or definitively related to the investigational product, (3) Grade ≥ 3 ICANS, (4) Grade ≥ 3 CRS and (5) Overall clinical grade ≥ 3 acute GvHD (MAGIC criteria)
Incidence and severity of treatment-related adverse events
Time frame: From first study drug administration to 4 weeks after last administration
7 secondary outcomes
Number of patients who received all infusions
Time frame: At the end of week 4
Number of infusions received per patient
Time frame: At the end of week 4
Time elapsed between confirmation of eligibility and first infusion
Time frame: At day 1
Percentage (%) of viable ThINKK cells at the time of infusion
Time frame: Day of infusion
Assessment of NK surface biomarkers
Time frame: From first study drug administration to 1 week after last administration
Assessment of plasmatic biomarkers by Olink®
Time frame: From first study drug administration to 1 week after last administration
Assessment of the global immune responses by single cell RNA sequencing
Time frame: Prior to first infusion and up to 1 week post last infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Background: PubMed 27716850Cordeau M, Belounis A, Lelaidier M, Cordeiro P, Sartelet H, Herblot S, Duval M. Efficient Killing of High Risk Neuroblastoma Using Natural Killer Cells Activated by Plasmacytoid Dendritic Cells. PLoS One. 2016 Oct 7;11(10):e0164401. doi: 10.1371/journal.pone.0164401. eCollection 2016.
- Background: PubMed 32342128Belounis A, Ayoub M, Cordeiro P, Lemieux W, Teira P, Haddad E, Herblot S, Duval M. Patients' NK cell stimulation with activated plasmacytoid dendritic cells increases dinutuximab-induced neuroblastoma killing. Cancer Immunol Immunother. 2020 Sep;69(9):1767-1779. doi: 10.1007/s00262-020-02581-0. Epub 2020 Apr 27.
- Background: PubMed 38754915Poirier N, Paquin V, Leclerc S, Lisi V, Marmolejo C, Affia H, Cordeiro P, Theoret Y, Haddad E, Andelfinger G, Lavallee VP, Duval M, Herblot S. Therapeutic Inducers of Natural Killer cell Killing (ThINKK): preclinical assessment of safety and efficacy in allogeneic hematopoietic stem cell transplant settings. J Immunother Cancer. 2024 May 15;12(5):e008435. doi: 10.1136/jitc-2023-008435.
- Background: PubMed 28555259Diaz-Rodriguez Y, Cordeiro P, Belounis A, Herblot S, Duval M. In vitro differentiated plasmacytoid dendritic cells as a tool to induce anti-leukemia activity of natural killer cells. Cancer Immunol Immunother. 2017 Oct;66(10):1307-1320. doi: 10.1007/s00262-017-2022-y. Epub 2017 May 29.
- Background: PubMed 26320191Lelaidier M, Diaz-Rodriguez Y, Cordeau M, Cordeiro P, Haddad E, Herblot S, Duval M. TRAIL-mediated killing of acute lymphoblastic leukemia by plasmacytoid dendritic cell-activated natural killer cells. Oncotarget. 2015 Oct 6;6(30):29440-55. doi: 10.18632/oncotarget.4984.
- Background: PubMed 23064038Charrier E, Cordeiro P, Brito RM, Mezziani S, Herblot S, Le Deist F, Duval M. Reconstitution of maturating and regulatory lymphocyte subsets after cord blood and BMT in children. Bone Marrow Transplant. 2013 Mar;48(3):376-82. doi: 10.1038/bmt.2012.176. Epub 2012 Oct 15.
- Background: PubMed 25128615Charrier E, Cordeiro P, Brito RM, Harnois M, Mezziani S, Herblot S, Le Deist F, Duval M. Impaired interferon-alpha production by plasmacytoid dendritic cells after cord blood transplantation in children: implication for post-transplantation toll-like receptor ligand-based immunotherapy. Biol Blood Marrow Transplant. 2014 Oct;20(10):1501-7. doi: 10.1016/j.bbmt.2014.06.007. Epub 2014 Aug 14.
- Individual participant dataSharing planned: Undecided. Currently reviewing our local regulations about individual patient data sharing (Canada)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michel Duval, MD principal investigator
St. Justine's Hospital
Sabine Herblot, PhD study director
St. Justine's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Therapeutic Inducers of Natural Killer Killing (ThINKK) in people with Leukaemia (Acute Lymphoblastic) and Leukaemia (Acute Myeloid), run by Michel Duval at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michel Duval, MD (5143454931 ext. 6746, michel.duval@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events and serious adverse events (time frame: From first study drug administration to 4 weeks after last administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07518654, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.